Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers
A Phase 1 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Safety and Immunogenicity of a Multiantigen HIV (HIV-MAG) pDNA Vaccine With or Without Human IL-12 pDNA GENEVAX® IL-12) and Ad35-GRIN/ENV Vaccine in HIV-Uninfected, Healthy Volunteers
1 other identifier
interventional
75
3 countries
3
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 19, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedSeptember 2, 2013
August 1, 2013
1.2 years
December 19, 2011
August 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
To evaluate the safety and tolerability of HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens.
13 months approximately
Secondary Outcomes (1)
Immunogenicity
12 months
Study Arms (5)
Group 1: HIV-MAG followed by Ad35-GRIN/ENV
EXPERIMENTALHIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3)
Group 2: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
EXPERIMENTALHIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo=12/3)
Group 3: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
EXPERIMENTALHIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo= 12/3)
Group 4: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
EXPERIMENTALHIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3)
Group 5: Ad35-GRIN/ENV followed by HIV-MAG+GENEVAX® IL-12
EXPERIMENTALAd35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3)
Interventions
Delivered intramuscularly by in vivo electroporation
Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation
Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation
(2x10\^10vp) Delivered intramuscularly by standard needle injection
Eligibility Criteria
You may qualify if:
- healthy male or female adults,
- to 50 years of age (21 to 50 years of age for volunteers in Rwanda),
- who do not report high-risk behaviour for HIV infection,
- who are available for the duration of the trial,
- who are willing to undergo HIV testing,
- use an effective method of contraception, and
- who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.
You may not qualify if:
- confirmed HIV infection,
- pregnancy and lactation,
- significant acute or chronic disease,
- clinically significant laboratory abnormalities,
- recent vaccination or receipt of a blood product,
- previous receipt of an HIV vaccine, and
- previous severe local or systemic reactions to vaccination or history of severe allergic reactions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International AIDS Vaccine Initiativelead
- Auro Vaccines LLCcollaborator
- Ichor Medical Systems Incorporatedcollaborator
Study Sites (3)
Kenya AIDS Vaccine Initiative, Kangemi
Nairobi, Kenya
Projet San Francisco
Kigali, Rwanda
Uganda Virus Research Institute-IAVI
Entebbe, Uganda
Related Publications (2)
Mpendo J, Mutua G, Nanvubya A, Anzala O, Nyombayire J, Karita E, Dally L, Hannaman D, Price M, Fast PE, Priddy F, Gelderblom HC, Hills NK. Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial. PLoS One. 2020 May 29;15(5):e0233151. doi: 10.1371/journal.pone.0233151. eCollection 2020.
PMID: 32469893DERIVEDMpendo J, Mutua G, Nyombayire J, Ingabire R, Nanvubya A, Anzala O, Karita E, Hayes P, Kopycinski J, Dally L, Hannaman D, Egan MA, Eldridge JH, Syvertsen K, Lehrman J, Rasmussen B, Gilmour J, Cox JH, Fast PE, Schmidt C. A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of Electroporated HIV DNA with or without Interleukin 12 in Prime-Boost Combinations with an Ad35 HIV Vaccine in Healthy HIV-Seronegative African Adults. PLoS One. 2015 Aug 7;10(8):e0134287. doi: 10.1371/journal.pone.0134287. eCollection 2015.
PMID: 26252526DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2011
First Posted
December 22, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Last Updated
September 2, 2013
Record last verified: 2013-08